510(k) · Cleared
ClearedMitek Mini Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · DZL Screw, Fixation, Intraosseous
Cleared on Nov 2, 1999 as substantially equivalent to K921873 (Mitek Surgical Products, Inc., 1992) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1992. 14 later devices descend from it.
- Decided
- Nov 2, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K921873 (1992). 3 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- This deviceK992623 Mitek Mini AnchorMitek Products · 1999
- Descendant · cites it directly · 12 of its ownK030995 Minilok Quickanchor PlusMitek Worldwide · 2003
- Descendant · cites it directly · 8 of its ownK071257 Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007
- Descendant · 2 generations on · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK153585 Flip Button Suture AnchorFirst Ray, LLC · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K030995Minilok Quickanchor PlusMitek Worldwide · 2003 · cites it directly12descendants
- K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007 · cites it directly8descendants
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · 2 generations on1descendant
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 2 generations on1descendant
- K153585Flip Button Suture AnchorFirst Ray, LLC · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| 0 (this device) | K992623 | Mitek Mini Anchor | Mitek Products | 1999 | — |
| +1 | K030995 | Minilok Quickanchor Plus | Mitek Worldwide | 2003 | — |
| +1 | K071257 | Mini Quickanchor and Quickanchor Plus with Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2007 | — |
| +2 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +2 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +2 | K153585 | Flip Button Suture Anchor | First Ray, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921873 | Quickanchor, ModificationSummary page 1…on: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class I1. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K921873 - Mitek Mini Anchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described in this S… | 1992 |
| * | K930892 | Mitek Mini Anchor, ModificationSummary page 1…of the Federal Food, Drug, and Cosmetic Act, the device classification is Class I1. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K921873 - Mitek Mini Anchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described in this S10(k) is a sterile, disposabl… | 1994 |
| * | K936311 | Mitek Mini AnchorSummary page 1…nd Cosmetic Act, the device classification is Class I1. Product Code: JDR (21 CFR 888.3030) Predicate Devices: K921873 - Mitek Mini Anchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described in this S10(k) is a sterile, disposable bone anchor consisting of… | 1995 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Shoulder: Bankart Repair
Ankle: Midfoot Reconstructions
Foot: Hallux Valgus Reconstruction
Wrist: Scapholunate Ligament Reconstruction
Hand: Ulnar or Lateral Collateral Ligament Reconstruction
Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence
The Mitek Mini Anchor is also indicated for the repair, repositioning or reattachment of soft tissues, ligaments and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992623: Mitek Mini Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992623
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026